Smarter Sole Survival: Will Neuropathic Patients at High Risk for Ulceration Use a Smart Insole-Based Foot Protection System?

Abstract

Objective: This study examined adherence to alert-based cues for plantar pressure offloading in patients with diabetic foot disease. Method and Design: Participants (n = 17) with in diabetic foot remission (history of neuropathic ulceration) were instructed to wear a smart insole system (the SurroSense Rx, Orpyx Medical Technologies Inc, Calgary, Canada) over a three-month period. This device is designed to cue offloading to manage unprotected sustained plantar pressures in an effort to prevent foot ulceration. A successful response to an alert was defined as pressure offloading, which occurred within 20 minutes of the alert onset. Patient adherence, defined as daily hours of device wear, was determined using sensor data and patient questionnaires. Changes in these parameters were assessed monthly. Results: Patients demonstrating increased adherence over the course of the study received more alerts (0.82 ± 0.31 alerts/hour) than patients whose adherence did not improve (0.36 ± 0.46 alerts/hour, P = .156). By the final stages of the study, participants who had received at least one alert every two hours were more adherent with offloading than participants who received fewer alerts (52.5 ± 4.1% vs 24.7 ± 22.4%, P = .043). Furthermore, duration of time from alert generation to successful offloading was significantly greater in the group receiving fewer alerts. This was measured in the third month with an effect size Cohen’s d = 1.739, P = .043. Conclusion: The results suggest a minimum number of alerts (one every two hours) is required for patients with diabetic neuropathy to optimally respond to offloading cues from a smart insole system.

Leveraging smart technologies to improve the management of diabetic foot ulcers and extend ulcer‐free days in remission

“…A recent study by Najafi et al study has also demonstrated the benefit of real‐time feedback to improve adherence to footwear. This figure is built based on results reported by Najafi et al study…”

“…This technology could be used to educate patients to avoid conditions leading to sustained plantar pressure (eg, unbroken and prolonged standing), which in turn could assist with prevention of diabetic foot ulcers. A recent study by Najafi et al study 39 has also demonstrated the benefit of real-time feedback to improve adherence to footwear. This figure is built based on results reported by Najafi et al study 39 confirm the offloading device was worn during those activities, a notification is provided to the patient via the smart watch and text message is sent to a patient's caregiver to encourage use of the offloading device.…”

“…A recent study by Najafi et al study 39 has also demonstrated the benefit of real-time feedback to improve adherence to footwear. This figure is built based on results reported by Najafi et al study 39 confirm the offloading device was worn during those activities, a notification is provided to the patient via the smart watch and text message is sent to a patient's caregiver to encourage use of the offloading device. In addition, the platform enables reporting daily adherence to offloading to care providers.…”

“…Such development may also have the possibility to engage neuropathic patients to be part of their routine daily foot care and change their attitude toward using protected footwear and safe mobility. In 2017, Najafi et al tested effectiveness of a real‐time alerting system (using a smart watch) to improve adherence to prescribed diabetic shoes over time. Participants were asked to wear on daily basis a pair of diabetic shoes equipt with a thin (< 0.5 mm) smart insole system, (the SurroSense Rx, Orpyx Medical Technologies Inc., Calgary, Canada; Figure ) over a 3‐month period.…”

“…They concluded that a real‐time and comprehensive foot pressure alert method with a minimum number of alerts (one every 2 hours) are effective to allow optimal response to offloading cues from a smart insole system and for improving adherence to prescribed diabetic shoes over time. This could be explained by the fact that a real‐time alert about comprehensive harmful weight‐bearing physical activities (activities such as prolonged bout of standing that may occlude capillary bed perfusion in the soft tissues of the foot for significant period of time and potentially damage the tissue or leading to local ischemia), may assist in improving perception of benefit of the technology, which in turn could improve the attitude toward using the protected footwear. This same technology has recently been shown to be effective for reducing DFU recurrence in patients with a previous history of DFU as part of an 18‐month proof‐of‐concept clinical control trial …”